Kornimate/medical-research-clean huggingface dataset:
comparison of the viveve treatment and cryogen-only treatment versus sham treatment for stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: this is a prospective, randomized, single-blind, study comparing both the viveve treatment (rf plus cryogen) and cryogen alone treatment versus sham treatment in patients with mild to moderate stress urinary incontinence.


Eligibility criteria:
inclusion criteria: * pre-menopausal females, ≥ 18 years of age. premenopausal is defined as a woman who has had menstrual cycles over the previous 12 months. * subjects with a bmi of ≤ 35 kg/m². * 1-hr pad weight at baseline with a 5 to 50 g net increase from the pre-test pad weight exclusion criteria: * subjects who are currently breastfeeding or have discontinued breastfeeding fewer than 6 months prior to screening. * subjects who are pregnant or plan to become pregnant during the course of the study. * subjects who have undergone other stress urinary incontinence treatments, excluding behavioral modifications (e.g., kegel exercises). * has any implantable electrical device \[e.g., implantable pacemaker, automatic implantable cardioverter-defibrillator (aicd)\]. * subjects who have started or changed dose of local vaginal hormones \<6 weeks before screening. * subjects who have started pelvic floor physical therapy within the last 3 months. * undergone previous elective surgical or non-invasive procedure(s) in the vaginal canal (including the viveve treatment or any other genital radiofrequency treatment; injectable bulking agent, cosmetic, laser, surgical, and/or genital enhancement procedure, and previous dilation and cuterage within 12 months of the subject's pre-screening visit).
study of a dialysate without acetate on protein energy wasting syndrome in chronic hemodialysis patient (easy)

Conditions: End Stage Renal Disease; Hemodialysis

Summary: this work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. the hypothesis is that a dialysate without acetate would improve patients nutritional status

the dialysate usually used at the clermont ferrand chu dialysis center is a dialysate containing acetate after inclusion, patients will be randomly divided into two groups. patients in group 1 will first be treated with the acetate-free dialysate (a-d) for 6 months and then the acetate-containing dialysate (a + d) for 6 months. group 2 patients will continue on the usual dialysate (a + d) for 6 months and then switch to a-d dialysate for the next 6 months. patients will be blinded from study treatment. patients will be followed for 1 year. a the beginning then every 3 months will be carried out: * a measurement of body composition by multi-frequency bioimpedancemetry * a measurement of the gripping force by a dynamometer (hand grip force ) * a 4-meter walk test * a sarc-f sarcopenia assessment questionnaire a blood test for the usual biological analyzes carried out as part of the recommendations for monitoring patients on hemodialysis will be carried out every month. an additional blood sample (5.5 ml) for quantification of the levels of expression of potential blood biomarkers of muscle condition will be taken initially, at 6 months and at 12 months (i.e. 16.5 ml more compared to current practice). ).

Eligibility criteria:
inclusion criteria: * major patient; * man or woman ; * treated with intermittent hemodialysis for chronic renal failure; * affiliated with a social security scheme; * having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it exclusion criteria: * patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by bcm in this situation) * acute event in the 3 months preceding inclusion (infection, surgery). * having a neuromuscular pathology responsible for a motor deficit. * whose life expectancy does not exceed 6 months * with a psychiatric pathology or cognitive impairment rendering him unable to give informed consent * pregnant women * patient under guardianship, curatorship or legal protection

Keywords: acetate free dialysate hemodialysis
cold application on the subcutaneous injection

Conditions: Injection Site Bruising; Bruising; Pain

Summary: the goal of this clinical trial is to compare the effect of cold application at different periods of time on the occurrence of bruising, haematoma and pain in the subcutaneous low molecular weight heparin (lmwh) injected patients.

the study was a single-blind randomised control trial. patients were allocated randomly to three groups: (i) cold was applied for two minutes before the injection in the first group (n=26); (ii) cold was applied for 5 min before the injection in the second group (n=26); and (iii) control group (n=26). all participating patients were injected 40 mg enoxaparin sodium in 0.4 ml in the pre-filled syringes using standard lmwh injection protocol. post-injection vas (visual analogue scale) assessment and assessment of the presence and size of bruise and haematoma were conducted at 48th and 72nd hours after the injections for all groups.

Eligibility criteria:
inclusion criteria: * to receive lmwh (pre-filled syringe containing 40 mg enoxaparin sodium in 0.4 ml) treatment at least once a day * not to have any visual or auditory disorders * not to have any foreknown coagulation disorders * to have platelet, ptt and international normalized ratio (inr) values within the normal limits for beginning enoxaparin sodium injections * not to have any hematologic disorders or any bruising or injuries at the abdominal wall * to receive no injections at the abdominal site, other than the enoxaparin sodium during the research protocol * to will to participate in this study exclusion criteria: * to be pregnant * have bleeding in the injection site * have pain at any site of their body prior to the injection * have any incision, drain, scar tissue, lipodystrophy or infection symptoms at the abdominal site which hinder the application of injection * not to will to participate in this study

Keywords: bruising cold application haematoma low molecular weight heparin nursing pain subcutaneous injection
estimation of effect of ketoconazole on pharmacokinetics of crizotinib in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female of non-child bearing potential subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * subjects with evidence of disease, conditions affecting drug absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, and use of prescription , nonprescription drugs and dietary supplement within 7 days, and blood donation of 500 ml within 56 days.

Keywords: crizotinib healthy volunteers ketoconazole pharmacokinetics single dose
evaluation of the safety and efficacy of ketotifen 4.0% patch as compared to placebo patch, olopatadine 0.2% ophthalmic solution, and artificial tears in the conjunctival allergen challenge (cac) model of acute allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: this is a phase 2 study that will consist of 4 visits over a 5 week period. drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * 18 years of age of either sex and any race * positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months * able and willing to avoid all disallowed medication for the washout period and during the study exclusion criteria: * active ocular infection or skin condition * ocular surgery within the past 3 months * pregnancy or nursing
anaesthesia for mechanical thrombectomy

Conditions: Stroke, Ischemic; Anesthesia

Summary: title: conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy. design: this study will be a retrospective consecutive observational case series

the aim of this study is to describe the baseline characteristics, procedural and post-operative clinical characteristics of anaesthetic care delivered to consecutive adult patients who underwent mechanical thrombectomy as part of their routine clinical care between 01/01/2016 and 01/10/2020 at nottingham university hospitals nhs trust (sample size approximately 250).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * undergone mechanical thrombectomy for the management of acute ischaemia stroke between 01/01/2016-01/10/2020 at nottingham university hospitals nhs trust. exclusion criteria: * no pre-specified exclusion criteria.

Keywords: anaesthesia ischaemic mechanical case series endovascular thrombectomy stroke
the effect of oral niacinamide on plasma phosphorus levels in peritoneal dialysis patients

Conditions: Hyperphosphatemia

Summary: hyperphosphatemia is common in the peritoneal dialysis population. current strategies are insufficient to optimize phosphorus control. animal studies have shown niacinamide, a form of vitamin b, to reduce phosphate uptake by the rat small intestine. our trial investigates the use of niacinamide, in addition to standard phosphorus lowering strategies, to reduce plasma phosphorus levels in peritoneal dialysis patients versus placebo.

this is a prospective, randomized, double-blind, placebo-controlled 8-week clinical trial to evaluate the efficacy of niacinamide versus placebo to reduce plasma phosphorus levels in peritoneal dialysis patients. patients on a stable regimen of phosphate binders with plasma phosphorus levels \> 4.9 mg/dl are eligible for enrollment and randomization. the study will span 8 weeks of active medication treatment. the primary end-point will be absolute change in plasma phosphorus levels. sixteen patients (8 randomized to each treatment arm) are needed to detect a 1.5 mg/dl difference assuming a standard deviation of 1 and powered at 80% (alpha 0.05). placebo will be packaged to resemble the study drug in all physical attributes. the starting dose of niacinamide will be 250 mg twice daily to be titrated to 500 mg twice daily at the end of week 2 with a final titration to 750 mg twice daily at the end of week 4. secondary end-points will include absolute change in the calcium-phosphorus product, intact parathyroid hormone, hemoglobin, platelet count, total cholesterol, hdl cholesterol, and percentage change in plasma phosphorus.

Eligibility criteria:
inclusion criteria: * age \> 18 years * capable of giving informed consent * duration of peritoneal dialysis \> 3 months * dose of phosphate binder(s) stable over previous 2 week period * plasma phosphours \> 4.9 mg/dl based on most recent laboratory data within 1 month of enrollment exclusion criteria: * pregnancy * known liver disease * active peptic ulcer disease * treatment with carbamazepine * intolerance to niacinamide or niacin * current medication regimen including niacin or niacinamide \> 100 mg daily * planned or expected surgical procedure in the next 4 months * patients in nursing home or extended care facilities where administration of the study drug may not be appropriately given

Keywords: hyperphosphatemia niacinamide esrd peritoneal dialysis renal osteodystrophy
multi-omics analysis to characterize the invasive evolution of pulmonary subsolid nodules

Conditions: Adenocarcinoma of Lung

Summary: current clinical follow-up frequency and treatment timing for pulmonary subsolid nodules (ssns) rely mostly on whether the nodules grow, which may not accurately reflect the pathological status, and may lead to unnecessary follow-ups. this study aims to use multi-omics techniques to dynamically observe the growth and invasiveness evolution process of ssns and uncover its invasiveness mechanism. radiological characteristics of ssns in different invasiveness stages were also analyzed and summarized by analyzing preoperative ct. this can overcome the bottleneck of invasiveness assessment in the growth process of ssn and provide scientific evidence for the scientific management and clinical treatment timing choice of ssn patients, thus facilitating the rational allocation of medical resources and prolonging the expected survival of national health.

this prospective observational cohort study aims to recruit 120 patients with subsolid nodules (ssns) and 100 healthy volunteers. enroll 120 patients with ssns planned for surgery and 100 healthy volunteers. sequence blood and tissue samples from patients and compare the relevance of biomarkers between the two. use blood from healthy volunteers as blank controls. additionally, analyzes radiological characteristics of ssns at different invasive stages using preoperative ct.

Eligibility criteria:
inclusion criteria: patients with ssns 1. newly diagnosed patients with persistent ssns confirmed by thin-section chest ct examination 2. patient areilling to undergo surgery 3. voluntarily sign a written informed consent form healthy volunteers 1. healthy volunteers aged 18-50 years, regardless of gender. 2. no lung nodules detected on chest thin-section ct. 3. no history of cancer. 4. voluntary sign a written informed consent form. exclusion criteria: patients with ssns 1. surgical contraindications 2. inability to cooperate with ct/mr examination to obtain high-quality images 3. history of malignant tumors 4. previous targeted, immune, or ablation therapy 5. postoperative pathology of non-lung adenocarcinoma disease spectrum 6. other situations deemed unsuitable for participation in this study by the researchers healthy volunteers 1. drug abuse 2. hiv infection or aids 3. history of syphilis, gonorrhea, or other infectious diseases 4. hepatitis b or c virus carrier

Keywords: subsolid nodule invasive evolution
practice-based trial of home bp telemonitoring among minority stroke survivors

Conditions: Stroke; Hypertension

Summary: this study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk black and hispanic stroke patients. the primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the united states.


Eligibility criteria:
inclusion criteria: * black or hispanic * age 18 years or older * english or spanish speaking * patients who have had an ischemic or hemorrhagic stroke * modified rankin scale score of ≤ 3 * average screening sbp ≥ 140 mm hg from three bp readings taken at two separate visits with a validated automated device * receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years. exclusion criteria: * being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the hbptm or interacting with the ncm if he/she were to be randomized to the intervention group) * participation in other clinical trials * diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record) * patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large bp cuff * diagnosis of dialysis or end stage renal disease * relocating out of area or extended travel during study period * significant verbal speech impairment; unable to participate in intervention telephone sessions * pregnant women
a clinical study to evaluate the efficacy and satisfaction of the skinceuticals skin care product (ce ferulic) for skin repair post fraxel laser treatment

Conditions: Photo-damaging

Summary: a prospective, single-center, single-blind, randomized split-face, controlled trial will be conducted. the goal of this clinical trial is to evaluate the efficacy and satisfaction of the skinceuticals skin care product (ce) for skin repair following fraxel laser treatment and explore the medical value of fraxel laser therapy combined with skinceuticals skin care product


Eligibility criteria:
inclusion criteria: 1. chinese subjects aged 18-65 years (inclusive); 2. subjects with fitzpatrick skin type ii-iv; 3. subjects with mild to moderate facial photoaging lesions, including melasma, acne scars, fine skin lines, enlarged pores, and dark photoaging problems 4. subjects with consistent facial skin status on both sides and planned to receive fraxel laser treatment; 5. subjects are willing to follow the requirements of the study protocol and complete the corresponding procedures; 6. subjects understand the nature of the study and sign the informed consent form (icf) exclusion criteria: 1. subjects with photosensitive skin or photosensitization-related diseases; 2. subjects with a history of skin pigmentation, such as pigmentation caused by sex hormone factors (pregnancy, oral contraceptives); 3. subjects with hypertrophic scar or scar constitution; 4. subjects with autoimmune diseases, endocrine diseases or liver diseases that may lead to skin color changes; 5. subjects who have received steroid/phototoxic drugs or laser treatment on the face within 3 months before enrollment; 6. subjects with a history of sun exposure within 2 weeks prior to enrollment; 7. subjects who are known to be contraindicated to fraxel laser therapy or ce (or allergic to other skin care components); 8. subjects with known infection and inflammation in the intended treatment site; 9. female subjects who are pregnant, lactating or plan to become pregnant; 10. subjects who plan to use other drugs affecting skin color or intend to undergo other laser therapy and sunbathing during the treatment; 11. subjects who are participating in other drug or medical device clinical trials; 12. other subjects who are not suitable for this study as assessed by the investigator
ambulatory liver fat monitoring in patients with non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: non-alcoholic fatty liver disease (nafld) affects 25% of the global population and causes serious complications, including cirrhosis, hepatocellular carcinoma or mortality. unfortunately, there are not yet any approved drugs to treatment nafld. the only effective means to improve nafld is by weight reduction via lifestyle modifications, i.e., diet and physical activity. most nafld patients lack the motivation to initiate and maintain lifestyle modifications. the investigators hypothesize that ambulatory monitoring of liver fat can help nafld patients lose more liver fat by motivating them to gain a sense of control over their condition.

as nafld is a chronic medical illness, nafld patients are not able to receive timely feedback from their effort, and they are often frustrated. also, living with nafld may not cause major perturbations to their usual life, as nafld is mostly asymptomatic and patients can easily forget the significance of this condition in the long run. the investigators plan to design a randomized, controlled, non-blinded, multi-centre study to compare the effects of ambulatory liver fat monitoring and standard of care in reduction of liver fat in nafld patients. fibroscan and mri-pdff will be used for quantification of hepatic steatosis. apart from the effect on liver fat, the investigators will also investigate whether ambulatory liver fat monitoring promotes more weight loss and improvement in liver biochemistry.

Eligibility criteria:
inclusion criteria: * patients with known nafld (diagnosed by ultrasonography or other forms of imaging; transient elastography with controlled attenuation parameter \>248 db/m; or liver biopsy) who are managed in the liver clinics of queen mary hospital or tung wah hospital * aged 18-65 years * without major cognitive impairment - since these subjects would be given simple instructions on using the ambulatory device to measure liver fat at home by themselves exclusion criteria: * on sglt-2 inhibitors, glp-1 agonists, or thiazolidinediones due to their prominent effects on body weight changes * patients with cirrhosis (defined by imaging features of nodular liver and evidence of portal hypertension, liver stiffness \>13 kpa, endoscopically proven gastroesophageal varices, or histological features), with or without ascites * patients who are pregnant * patients on special diet or with special dietary requirement (e.g., vegan, gluten free) heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men) * history of hcc, hepatic resection, or lt * patients with damaged skin on the abdomen, as this will affect the assessment by the ambulatory liver fat device * patients with implanted electronic devices * patients with spinal diseases/ discomfort * patients with metallic implants

Keywords: ambulatory monitoring